PDA TECHNICAL REPORTS

TECHNICAL REPORT

TITLE

DATE OF PUBLICATION

Paper
Version

Digital
Version

01001

43381

Validation of Moist Heat Sterilization Processes: Cycle Design, Development,

Qualification and Ongoing Control

1980 (Revised 2007)

43506

Validation of Dry Heat Processes Used for Sterilization and Depyrogenation

1981 (Revised 2013)

01004

43209

Design Concepts for the Validation of Water-for-Injection Systems

1983

01005

43210

Sterile Pharmaceutical Packaging: Compatibility and Stability

1984

01007

43212

Depyrogenation

1985

01009

43214

Review of Commercially Available Particulate Measurement Systems

1988

01010

43215

10

Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers

1988

01011

43216

11

Sterilization of Parenterals by Gamma Radiation

1988

01012

43217

12

Siliconization of Parenteral Drug Packaging Components

1988

43218

13

Fundamentals of an Environmental Monitoring Program

1990 (Revised 2001)

01014

43220

14

Validation of Column-Based Chromatography Processes for the Purification of

Proteins

1992 (Revised 2008)

01015

43221

15

Validation of Tangential Flow Filtration in Biopharmaceutical Applications

1992 (Revised 2009)

01016

43222

16

Effect of Gamma Irradiation on Elastomeric Closures

1992

01017

43223

17

Current Practices in the Validation of Aseptic Processing -- 1992

1993

01018

43224

18

Report on the Validation of Computer-Related Systems

1995

01019

43225

19

Rapid/Automated ID Methods Survey

1990

01020

41239

20

Report on Survey of Current Industry Gowning Practices

1990

01021

41258

21

Bioburden Recovery Validation

1990

43226

22

Process Simulation Testing for Aseptically Filled Products

43227

23

Industry Survey on Current Sterile Filtration Practices

1996

43228

24

Current Practices in the Validation of Aseptic Processing -- 1996

1996

43229

25

Blend Uniformity Analysis: Validation and In-Process Testing

1997

43230

26

Sterilizing Filtration of Liquids

43231

27

Pharmaceutical Package Integrity

01028

43232

28

Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

1998 (Revised 2006)

01029

43501

29

Points to Consider for Cleaning Validation

1998 (Revised 2012)

43234

30

Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat

1999 (Revised 2012)

01031

43235

31

Validation and Qualification of Computerized Laboratory Data Acquisition Systems

01032

43236

32

Auditing of Suppliers Providing Computer Products and Services for Regulated

Pharmaceutical Operations

1999 (Revised 2004)

01033

43510

33

Evaluation, Validation and Implementation of New Microbiogical Testing Methods

2000 (Revised 2013)

01034

43239

34

Design and Validation of Isolate Systems for the Manufacturing and Testing of
Health Care Products

2001

01035

43240

35

A Proposed Training Model for the Microbiological Function in the Pharmaceutical

Industry

2001

01024

10/17/2013

1996 (Revised 2011)

1998 (Revised 2008)

1998

1999

TECHNICAL REPORT

TITLE

DATE OF PUBLICATION

Paper
Version
01036

Digital
Version
43241

36

Current Practices in the Validation of Aseptic Processing -- 2001

2002

01038

43315

38

Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC):

Chemistry, Manufacturing and Controls Documentation

2006

01039

43312

39

Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality

of Temperature-Sensitive Medicinal Products through the Transportation

2007

01040

43314

40

Sterilization Filtration of Gases

2005

01041

43313

41

Virus Filtration

2008

01042

43311

42

Process Validation of Protein Manufacturing

2005

43508

43

Identification and Classification of Nonconformities in Molded and Tubular Glass

Containers for Pharmaceutical Manufacturing

01044

43410

44

Quality Risk Management for Aseptic Processes

2008

01045

43422

45

Filtration of Liquids Using Cellulose-Based Depth Filters

2008

01046

43485

46

Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to
the End User

2009

43486

47

Preparation of Virus Spikes Used for Virus Clearance Studies

2010

43487

48

Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification

and Maintenance

2010

43488

49

Points to Consider for Biotechnology Cleaning Validation

2010

43489

50

Alternative Methods for Mycoplasma Testing

2010

43490

51

Biological Indicators for Gas and Vapor-Phase Decontamination Processes:

Specification, Manufacture, Control and Use

2010

43491

52

Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain

2011

43492

53

Guidance for Industry: Stability Testing to Support Distribution of New Drug

Products

2011

43493

54

Implementation of Quality Risk Management for Pharmaceutical and

Biotechnology Manufacturing Operations

2012

43504

54-2

54-2 Implementation of Quality Risk Management for Pharmaceutical and

Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for
Quality Risk Management in Packaging and Labeling

2013

43494

55

Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole

Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries

2012

43496

56

Application of Phase-Appropriate Quality Systems and CGMP to the Development

of Therapeutic Protein Drug Substance

2012

43497

57

Analytical Method Validation and Transfer for Biotechnology Products

2012

43499

58

Risk Management for Temperature-Controlled Distribution

2012

43500

59

Utilization of Statistical Methods for Production Monitoring

2012

01060

43502

60

Process Validation: A Lifecycle Approach

2013

01061

43503

61

Steam In Place

2013

43505

62

Recommended Practices for Manual Aseptic Processes

2013

43507

63

Quality Requirements for the Extemporaneous Preparation of Clinical Trial

2013

43509

64

Active Temperature-Controlled Systems

2013

01064

10/17/2013

2007 (Revised 2013)